Clinical Trial Details for

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT ID: NCT05882877

Last Updated: January 05, 2024

Official Title

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Purpose

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

The Study at a Glance

Status: RECRUITING

Phase: Phase 3

Gender: ALL

Age: 12 Years - 100 Years

Condition: Atopic Dermatitis

Study Type: Interventional

Lead Sponsor: Amgen

Eligibility

Ages Eligible for Study: 12 Years to 100 Years

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Inclusion Criteria: * Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days. Exclusion Criteria: * Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

Additional Information, Locations & Contacts

Collaborators: Not provided

Investigators: MD

Please refer to this study by its clinicaltrials.gov identifier: NCT05882877
Location

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Kern Research Inc

Bakersfield, California, United States

Hope Clinical Research LLC

Canoga Park, California, United States

West Coast Research LLC

Dublin, California, United States

California Dermatology and Clinical Research Institute

Encinitas, California, United States

First OC Dermatology

Fountain Valley, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Long Beach Research Institute

Long Beach, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Integrative Skin Science and Research

Sacramento, California, United States

University of California at Davis Medical Center

Sacramento, California, United States

Clinical Science Institute

Santa Monica, California, United States

Immunoe Health Centers

Centennial, Colorado, United States

Foxhall Research Center

Washington, District of Columbia, United States

Skin Care Research Incorporated

Boca Raton, Florida, United States

Saint Jude Clinical Research

Doral, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Savin Medical Group LLC

Miami Lakes, Florida, United States

Healthy Life Research

Miami, Florida, United States

Anchor Medical Research

Miami, Florida, United States

Innovation Medical Research Center Inc

Palmetto Bay, Florida, United States

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, United States

Advanced Medical Research PC

Sandy Springs, Georgia, United States

Treasure Valley Medical Research

Boise, Idaho, United States

DeNova Research

Chicago, Illinois, United States

The Indiana Clinical Trials Center PC

Plainfield, Indiana, United States

Options Research Group LLC

West Lafayette, Indiana, United States

Dermatology and Skin Cancer Center Leawood

Leawood, Kansas, United States

DS Research

Louisville, Kentucky, United States

Kentucky Advanced Medical Research LLC

Murray, Kentucky, United States

MetroBoston Clinical Partners

Brighton, Massachusetts, United States

Onyx Clinical Research

Flint, Michigan, United States

Revival Research Institute LLC

Troy, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, United States

Skin Specialists PC

Omaha, Nebraska, United States

Jubilee Clinical Research Inc

Las Vegas, Nevada, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Skin Cancer and Dermatology Institute

Reno, Nevada, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

The Skin Surgery Center

Winston-Salem, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

The Ohio State University Dermatology East

Gahanna, Ohio, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, United States

Essential Medical Research LLC

Tulsa, Oklahoma, United States

Velocity Clinical Research Inc

Medford, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

Paddington Testing Company Inc

Philadelphia, Pennsylvania, United States

DermDox Dermatology, LLC

Sugarloaf, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

Cumberland Skin Center

Hermitage, Tennessee, United States

US Dermatology Partners Jollyville

Austin, Texas, United States

US Dermatology Partners Cedar Park

Cedar Park, Texas, United States

Dermatology Treatment and Research Center PA

Dallas, Texas, United States

Zenos Clinical Research, LLC

Dallas, Texas, United States

Newco 3A Research LLC

El Paso, Texas, United States

Texas Dermatology Research Center

Plano, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Education and Research Foundation Inc

Lynchburg, Virginia, United States

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States

Conexa Investigacion Clínica S.A.

Caba, Distrito Federal, Argentina

CARE- Centro de Alergia y Enfermedades Respiratorias

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

Instituto de Neumonologia y Dermatologia

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

Psoriahue Medicina Interdisciplinaria SRL

Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina

Instituto de Diagnostico ABC

Rosario, Santa Fe, Argentina

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, Australia

Princess Alexandra Hospital

South Brisbane, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Emeritus Research Melbourne

Camberwell, Victoria, Australia

Skin Health Institute

Carlton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Beacon Dermatology

Calgary, Alberta, Canada

Laser Rejuvenation Clinics Edmonton D.T. Incorporated

Edmonton, Alberta, Canada

Alberta Derma Surgery Centre

Edmonton, Alberta, Canada

Vida Clinical Research

Edmonton, Alberta, Canada

Doctor Chih-Ho Hong Medical Incorporated

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

CCA Medical Research Corporation

Ajax, Ontario, Canada

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

SKiN Health

Coburg, Ontario, Canada

Kingsway Clinical Research

Etobicoke, Ontario, Canada

LEADER Research

Hamilton, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

DermEdge Research Incorporated

Mississauga, Ontario, Canada

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, Canada

Allergy Research Canada Incorporated

Niagara Falls, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

Canadian Dermatology Centre

North York, Ontario, Canada

The Centre for Clinical Trials Inc

Oakville, Ontario, Canada

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

JRB Research Incorporated

Ottawa, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

North York Research Inc.

Toronto, Ontario, Canada

Toronto Research Centre Inc

Toronto, Ontario, Canada

Research Toronto

Toronto, Ontario, Canada

Alliance Clinical Trials

Waterloo, Ontario, Canada

XLR8 Medical Research, Incorporated

Windsor, Ontario, Canada

Clinique de Dermatologie Rosemont

Montreal, Quebec, Canada

Innovaderm Research Inc

Montreal, Quebec, Canada

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada

Centre de Recherche Dermatologique du Quebec Metropolitain

Quebec, Canada

Dermamedica, sro

Nachod, Czechia

CCR Ostrava sro

Ostrava, Czechia

CCR Czech as

Pardubice, Czechia

Clintrial sro

Praha 10, Czechia

CCR Prague sro

Praha 3, Czechia

Praglandia sro

Praha 5, Czechia

Kozni ambulance Fialova sro

Praha 6, Czechia

Fakultni nemocnice Bulovka

Praha 8, Czechia

Dermamedest sro

Praha, Czechia

Dermatologicka ambulance MUDr Petr Trestik

Svitavy, Czechia

Gentofte Hospital

Hellerup, Denmark

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, France

Fachklinik Bad Bentheim

Bad Bentheim, Germany

Dermatologische Gemeinschaftspraxis-Mahlow

Blankenfelde-Mahlow, Germany

Hautarztpraxis Dr Niesmann und Dr Othlinghaus

Bochum, Germany

Rosenpark Research GmbH

Darmstadt, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Schleswig-Holstein

Kiel, Germany

Hautmedizin Saar

Merzing, Germany

Universitaetsklinikum Muenster

Muenster, Germany

KliFOs Klinische Forschung Osnabrueck

Osnabrueck, Germany

Universitaetsklinikum Tuebingen

Tuebingen, Germany

Helios Klinikum Wuppertal

Wuppertal, Germany

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, Greece

General Hospital Of Nea Ionia Konstantopouleio Patision

Nea Ionia, Greece

Trial Pharma Kft

Bekescsaba, Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvar, Hungary

DermaMed Research Kft

Oroshaza, Hungary

Allergo-Derm Bakos Kft

Szolnok, Hungary

Medmare Bt

Veszprem, Hungary

Obudai Egeszsegugyi Centrum Kft

Zalaegerszeg, Hungary

Fukui Dermatology Clinic

Nagoya-shi, Aichi, Japan

Japan Community Healthcare Organization Chukyo Hospital

Nagoya-shi, Aichi, Japan

Central Clinic

Nagoya-shi, Aichi, Japan

Miyata Dermatology Clinic

Matsudo-shi, Chiba, Japan

International University of Health and Welfare Narita Hospital

Narita-shi, Chiba, Japan

Ekihigashi Dermatology Allergy Clinic

Fukuoka-shi, Fukuoka, Japan

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, Japan

Matsuo Clinic

Fukuoka-shi, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima-shi, Fukushima, Japan

Asahikawa City Hospital

Asahikawa-shi, Hokkaido, Japan

Takagi Dermatological Clinic Branch

Obihiro-shi, Hokkaido, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo-shi, Hokkaido, Japan

Kobe University Hospital

Kobe-shi, Hyogo, Japan

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

Kaji Dermatology Clinic

Nonoichi-shi, Ishikawa, Japan

Iwate Medical University Uchimaru Medical Center

Morioka-shi, Iwate, Japan

Takeoka Dermatology Clinic

Marugame-shi, Kagawa, Japan

Katahira Dermatology Urology Clinic

Kagoshima-shi, Kagoshima, Japan

Kosugi Dermatology Clinic

Kawasaki-shi, Kanagawa, Japan

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, Japan

St Marianna University Hospital

Kawasaki-shi, Kanagawa, Japan

Nomura Dermatology Clinic

Yokohama-shi, Kanagawa, Japan

Showa University Northern Yokohama Hospital

Yokohama-shi, Kanagawa, Japan

Jouzan Hihuka Hinyoukika Clinic

Kumamoto-shi, Kumamoto, Japan

Suizenji Dermatology Clinic

Kumamoto-shi, Kumamoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto-shi, Kyoto, Japan

Rakuwakai Otowa Hospital

Kyoto-shi, Kyoto, Japan

Nagasaki University Hospital

Nagasaki-shi, Nagasaki, Japan

Osaka Habikino Medical Center

Habikino-shi, Osaka, Japan

Mochida Dermatology Clinic

Izumiotsu-shi, Osaka, Japan

Yoshioka Dermatology Clinic

Neyagawa-shi, Osaka, Japan

Dermatology and Ophthalmology Kume Clinic

Sakai-shi, Osaka, Japan

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu-shi, Shizuoka, Japan

Hamamatsu University Hospital

Hamamatsu-shi, Shizuoka, Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, Japan

Mildix Skin Clinic

Adachi-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Mita Dermatology Clinic

Minato-ku, Tokyo, Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, Japan

Yamate Dermatology Clinic

Shinjuku-ku, Tokyo, Japan

Sugamo Kobayashi Derma Clinic

Toshima-ku, Tokyo, Japan

Shirasaki Dermatology Clinic

Takaoka-shi, Toyama, Japan

Korea University Ansan Hospital

Ansansi, Gyeonggido, Korea, Republic of

The Catholic University of Korea Incheon St Marys Hospital

Incheon, Korea, Republic of

Inha University Hospital

Incheon, Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of

Korea University Anam Hospital

Seoul, Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of

National Medical Center

Seoul, Korea, Republic of

Konkuk University Medical Center

Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong

Seoul, Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of

The Catholic University of Korea Seoul St Marys Hospital

Seoul, Korea, Republic of

Chung-Ang University Hospital

Seoul, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital

Seoul, Korea, Republic of

Ewha Womans University Seoul Hospital

Seoul, Korea, Republic of

Ajou University Hospital

Suwon-si, Gyeonggi-do, Korea, Republic of

Outpatient clinic Veselibas Centrs 4

Riga, Latvia

Outpatient clinic Veselibascentrs 4

Riga, Latvia

Smite Aija practice in dermatology and venerology

Talsi, Latvia

Dermapolis Medical Dermatology Center dr n med Edyta Gebska

Chorzow, Poland

GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

Katowice, Poland

Ip Clinic Sp zoo

Lodz, Poland

DermMedica Spzoo Centrum Columbus

Wroclaw, Poland

Hospital Garcia de Orta, EPE

Almada, Portugal

Hospital Cuf Descobertas

Lisboa, Portugal

Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica

Banska Bystrica, Slovakia

Sanare spol sro

Svidnik, Slovakia

Hospital Universitario Reina Sofia

Cordoba, Andalucía, Spain

Hospital Universitario Virgen Macarena

Sevilla, Andalucía, Spain

Hospital General Universitario de Alicante

Alicante, Comunidad Valenciana, Spain

Hospital Arnau de Vilanova de Valencia

Valencia, Comunidad Valenciana, Spain

Hospital Universitario La Paz

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

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